English Chancery Court dismisses infringement suit by U.S. pharmaceutical company because narrow wording of its U.K. patent for osteoporosis medication left way open for defendant's lawful use of different form of sulphonic acid in similar manufacturing process
The plaintiff (or claimant), Merck & Co. Inc., is a pharmaceutical company incorporated in the United States. It owned patents in the U.S. and U. K. describing a way to make monosodium alendronate or MA. MA had proved useful in suppressing bone resorption. So many physicians worldwide were prescribing it to treat bone diseases such as osteoporosis that it may well be the most widely used treatment for that condition.
Generics (U.K.) Ltd. (the defendant) was in the business of supplying pharmaceutical products in the United Kingdom. At some point, it notified the plaintiff that it intended to market a medication in the U.K. in which MA made in India by a company called CIPLA would be the active ingredient.
It also furnished the plaintiff with a confidential explanation of the CIPLA process for making its product and gave the plaintiff a limited time to admit non infringement under the U.K. patent. Absent such a concession, defendant assured plaintiff that it planned to go to court to obtain a declaration to that effect.
Within the time limit, the plaintiff itself filed suit in the Chancery Division, an English court of first instance. The suit claimed infringement of claim 1 of its English Patent by the CIPLA method as depicted by the defendant. In effect, plaintiff urges that the CIPLA process appropriates the entire value of its invention. The Chancery Court, however, ends up dismissing plaintiff's claim.
Under the U. K. Patents Act of 1977 (the Act) and the European Patent Convention of 1973 (EPC) [13 I.L.M. 271(1974), 15 I.L.M. 5(1976)], the monopoly sought by a patentee clearly has to be comprehensible to the patent reader, the Court notes. The reader has to be able to define the limits of the prohibited field before he sets out to make a rival product or to install a competing process.
"A patent is a document written by the patentee for publication to the world at large and designed not only to set out clearly what the invention is but to describe the monopoly sought in unambiguous terms. It is supposed to be comprehensible to members of the relevant trade simply on reading." [¶ 34]
In the instant case, however, the notional reader of the Patent could not have been sure of the protective scope the plaintiff intended. For example, he would be uncertain whether that protection reached the use of any sulphonic acid in the manufacturing process as well as the methanesulfonic acid (MSA) specified in claim 1 of the Patent.
"[Plaintiff] was keen to focus on the CIPLA process and to say that, whatever the Patent's scope, that process fell within it. However, as noted above, the proper approach is to construe the Patent and its claims in the absence of the infringement and only when this has been done, to look at the [alleged] infringement. One of the advantages of this is that it allows one to appreciate the full breadth of the monopoly asserted." [¶ 23]
"A patent is a document written by the patentee for publication to the world at large and designed not only to set out clearly what the invention is but to describe the monopoly sought in unambiguous terms. It is supposed to be comprehensible to members of the relevant trade simply on reading. If our law has reached the stage where [as here] experiments and extensive expert evidence is admissible to aid in construing patents, then it suggests that something has gone wrong." [¶ 34]
"Whatever the judicial attempts to give guidance, the bedrock on which construction must be based consists of the statutory provisions which determine the form of a patent and the function of its parts. They are to be found in the Act ... and the ... EPC."
"The Act provides in part as follows: "Article 69 [of the EPC] should not be interpreted in the sense that the extent of the protection conferred by a European patent is to be understood as that defined by the strict, literal meaning of the wording used in the claims, the description and drawings being employed only for the purpose of resolving an ambiguity found in the claims. Neither should it be interpreted in the sense that the claims serve only as a guideline and that the actual protection conferred may extend to what, from a consideration of the description and drawings by a person skilled in the art, the patentee has contemplated. On the contrary, it is to be interpreted as defining a position between these extremes which combines a fair protection for the patentee with a reasonable degree of certainty for third parties." [¶ 35]
"It is [the patentee's] duty to communicate his invention and his assertion of monopoly to the public in language it will understand. He is warned by the Protocol that his exclusive rights will not necessarily extend to everything which, from a reading of the specification, it can be seen that he contemplated."
"Furthermore the drafting of the specification and claims has to be considered against the background that no one is forced to apply for a patent or to seek as wide protection as possible. The patentee can be taken to be aware of the fact that there is always a balance to be achieved between width of protection and validity. It is up to the patentee to choose the level of risk he wishes to run." [¶ 38]
"Notwithstanding the adaptability of scientific language, the patentee is not expected to be omniscient or to exhibit super human thoroughness in drafting. He may not be able to foresee future developments which will be useable with his invention but which make no material difference to the way it works."
"Furthermore the patentee may choose a form of language which emphasises which features of an invention are important and which are not. ... If there is a variant to the latter, which obviously does not affect the way in which the invention works, the notional reader may be reasonably confident that the inventor wanted to cover this variant as well. In these types of cases, the monopoly is likely to extend to the new variant." [¶ 42]
"The courts are not a branch of social services whose job it is to help the infirm or the unwise and the Protocol does not require them to be so. There is no cannon [sic] of construction which would justify the courts in granting a patentee more protection than that which, objectively assessed, he indicated he wanted. Indeed to do so would not be "fair' to the patentee. It could expose him to a greater risk of invalidity than he was prepared to shoulder [cite]." [¶ 47]
" ... I am not persuaded that the patent should be construed so as to give protection for the wider family of sulphonic acids. The claimant is caught on the horns of a dilemma. If, as the claimant asserts, it is obvious that other sulphonic acids besides MSA would work in the same way, then there are only two possibilities. Either the patentee, sharing the knowledge and skills of the notional addressee, must have been aware of this or he was not."
"In the former case, the decision to refer only to MSA in the specification and claims is likely to have involved a decision on his part not to seek protection for all the other sulphonic acids. In the latter case, he was not aware of the possibility of using any other sulphonic acid and in this respect the claim accurately reflects what he wanted a monopoly for."
"It is not necessary to consider which of these two possibilities is the most likely, but it is noticeable that the patentee not only does not refer to any other sulphonic acid or even hint that any other acid might work, but he ventures no opinion as to why MSA works and why the prior art failed."
"That lacuna is not filled by looking at the prior art referred to expressly in the patent. In particular, as noted above, [plaintiff's] U.S. Patent No 4,407,761, which uses chlorobenzene as the solvent and in which the product goes solid, does not refer to this as a defect, does not address the question of why it solidifies nor does it touch upon the reason why the solvent does not work (assuming, of course, that solution of the end product was something which that inventor was trying to achieve which is not what the U.S. patent suggests)."
"In my view the notional reader could not be reasonably confident that the inventor wanted to cover sulphonic acids other than MSA. ... [T]he reader is entitled to assume that the patentee thought at the time of the specification that he had good reason for limiting his monopoly to MSA and intended to do so. In those circumstances, to widen out the protection is not an act of fairness to the patentee, nor does it give reasonable certainty to third parties." [¶ 60].
For the above reasons, the Court holds that the importation of products made to the CIPLA process would not infringe the claimant's Patent. It therefore dismisses claimant's petition.
Citation: Merck & Co Inc. v. Generics (U.K.) Ltd., [2003] E.W.H.C. 2842 (PAT.), [2003] All E.R. (D) 418 (Nov.) (Chancery Division, Nov. 27).
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